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Behavioral Intervention

Cognitive Behavioral Therapy for Irritable Bowel Syndrome (U54_P3_CBT Trial)

N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to 55 years of age, inclusive
Must be absent of red flags including unexplained weight loss, fevers, anemia or blood in stools
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 5 years
Awards & highlights

U54_P3_CBT Trial Summary

This trial will use CBT to study the relationship between the brain, the gut microbiome, and symptomatic outcome in IBS patients, with the goal of identifying the role of sex differences in these relationships.

Who is the study for?
This trial is for men and women aged 18-55 with IBS, meeting ROME IV criteria. Women must be premenopausal, not pregnant or breastfeeding, and willing to use non-hormonal birth control. Participants should have no major psychiatric diagnoses or significant medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The effectiveness of Cognitive Behavioral Therapy (CBT) on IBS is being tested, focusing on sex differences in response. The study involves advanced neuroimaging and microbiome analysis before and after CBT to understand brain-gut-microbiome interactions.See study design
What are the potential side effects?
Since CBT is a type of psychotherapy involving talking and behavior modification strategies without medication, it typically does not cause physical side effects but may sometimes lead to temporary increases in distress as difficult topics are discussed.

U54_P3_CBT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I don't have unexplained weight loss, fevers, anemia, or blood in my stools.
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I can walk without relying solely on a wheelchair.
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I am a woman who has not gone through menopause and still gets periods.
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I can speak English fluently.
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I have been diagnosed with or show symptoms of Irritable Bowel Syndrome.

U54_P3_CBT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Degree of connectivity between brainstem nuclei and the salience, emotional arousal and sensorimotor networks brain networks.
Secondary outcome measures
Abundance of Clostridiales taxa
Irritable Bowel Symptom Severity scale (IBSSS)
KYN/TR ratio.
+1 more

U54_P3_CBT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Treatment ArmExperimental Treatment1 Intervention
Subjects in the "Cognitive Behavioral Treatment" Arm will undergo 8-10 weeks of remote cognitive behavioral therapy. Subjects will complete modules on their phones and will be monitored by study coordinators for support and treatment completion.
Group II: Usual Care ArmActive Control1 Intervention
Subjects in the "Usual Care" Arm will undergo 8-10 weeks of continued lifestyle. Subjects will be asked to report any new medications or lifestyle changes to study coordinators throughout the 8-10 weeks.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,279,284 Total Patients Enrolled
12 Trials studying Irritable Bowel Syndrome
1,078 Patients Enrolled for Irritable Bowel Syndrome

Media Library

Cognitive Behavioral Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05155631 — N/A
Irritable Bowel Syndrome Research Study Groups: Cognitive Behavioral Treatment Arm, Usual Care Arm
Irritable Bowel Syndrome Clinical Trial 2023: Cognitive Behavioral Therapy Highlights & Side Effects. Trial Name: NCT05155631 — N/A
Cognitive Behavioral Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05155631 — N/A
Irritable Bowel Syndrome Patient Testimony for trial: Trial Name: NCT05155631 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be a viable candidate to participate in this research?

"This trial is looking to include 150 patients who are aged between 18 and 55 with a diagnosis of irritable bowel syndrome."

Answered by AI

Is this study currently open to accept new participants?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively recruiting patients since it was posted on December 18th 2021 and recently revised on January 20th 2022. This trial necessitates 150 individuals from a single site for participation."

Answered by AI

Does the age range for participation in this study extend to those under 35?

"This trial specifically caters to individuals aged 18-55. For those younger than 18, there are 13 other trials available and for senior citizens over 65, 79 different studies may offer solutions."

Answered by AI

What is the sample size of this research project?

"Affirmative. According to clinicaltrials.gov, this medical study is actively recruiting patients; the trial was initially posted on December 18th 2021 and its most recent update took place on January 20th 2022. 150 participants are needed from 1 site for successful completion of the research."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
California
What site did they apply to?
UCLA
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

My intestinal issues are now interfering wit my day-to-day life. I have tried many different diets and supplements. I’ve also tried medications for SIBO, but nothing seems to last. I am often bloated and uncomfortable and it affects what clothing I can wear as I don’t know how bloated and uncomfortable I will be throughout the day. Sometimes I wake up bloated and sometimes it happens throughout the day. The only thing that seems to help is extreme dieting where I’m eating almost nothing, which is not healthy or sustainable.
PatientReceived 2+ prior treatments
~46 spots leftby Apr 2025